(112 days)
No
The summary describes standard endoscopic equipment for airway management and does not mention any AI/ML capabilities, image processing beyond basic visualization, or performance metrics typically associated with AI/ML algorithms.
No.
The device is designed for endoscopic observation, intubation, and management of the airway, which are diagnostic and procedural functions, not therapeutic.
Yes.
The device's intended use includes "endoscopic observation to access airway anatomy," which implies observing and assessing the state of the anatomy, a core function of a diagnostic device.
No
The device description explicitly mentions physical components like fiberscopes, videoscopes, video system centers, light sources, monitors, and suction pumps, and the performance studies include electrical and physical testing, indicating it is a hardware device with associated software.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly describes the devices as being used for airway management, including endoscopic observation and endotracheal/endobronchial intubation. This involves directly visualizing and manipulating structures within the body.
- IVD Definition: In vitro diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- Nature of the Device: These are fiberscopes/videoscopes used for direct visualization of the airway. They do not analyze biological specimens outside of the body.
Therefore, the function and intended use of these devices fall outside the scope of in vitro diagnostics. They are considered endoscopic devices used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Product codes
EOQ
Device Description
LF-P Device Description
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
LF-V Device Description
The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic observation
Anatomical Site
airway anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
- General
- ISO 14971 (Medical devices Application of risk management to medical I devices)
- Non-Clinical Bench Testing
- Electrical Testing:
- IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- 트 IEC 60601-1-2 (Medical electrical equipment - Part 1-2: Collateral Standard: Electromagnetic disturbances - Requirements and tests)
- I IEC 60601-2-18 (Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment)
- IEC 62471 (Photobiological safety of lamps and lamp systems)
- Performance Testing:
- I ISO 8600 (Endoscopes - Medical endoscopes and endotherapy devices, Part 1: General requirements)
- Composite durability
- I Color performance
- 트 Image intensity uniformity (IIU)
- Field of View and Direction of View
- 트 Resolution
- Electrical Testing:
- Reprocessing:
- FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- Biocompatibility
- ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and 트 testing within a risk management process)
- I ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
- 트 ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for skin sensitization)
Clinical and animal testing were not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 26, 2022
Olympus Medical Systems Corp. % Brenda Geary Manager, Regulatory Affairs Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581
Re: K221631
Trade/Device Name: Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: August 19, 2022 Received: August 19, 2022
Dear Brenda Geary:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221631
Device Name
Tracheal Intubation Fiberscope OLYMPUS LF-P VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V
Indications for Use (Describe)
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in blue, with a registered trademark symbol next to it. Below the word is a yellow and orange graphic. To the right of the word "OLYMPUS" is the alphanumeric code "K221631".
Date Prepared: June 3, 2022
510(k) Summary
A. SPONSOR INFORMATION
| 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi,
Tokyo, Japan 192-8507 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Brenda Geary
Olympus Corporation of the Americas
800 West Park Drive
Westborough, MA 01581
Cell: (928) 707-2852
Email: brenda.geary@olympus.com |
Official Correspondent: Brenda Geary
B. DEVICE IDENTIFICATION
| ■ Device Name(s): | TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P
VISERA TRACHEAL INTUBATION VIDEOSCOPE
OLYMPUS LF TYPE V |
|-------------------------|-----------------------------------------------------------------------------------------------------------|
| ■ Model Name(s): | OLYMPUS LF-P, OLYMPUS LF-V |
| ■ Common Name: | Tracheal Intubation Videoscope |
| ■ Regulation Number: | 874.4680 |
| ■ Regulation Name: | Bronchoscope (flexible or rigid) and accessories |
| ■ Regulatory Class: | II |
| ■ Product Code: | EOQ: Bronchoscope (Flexible or Rigid) |
| ■ Classification Panel: | Division of Dental and ENT Devices (DHT1B) |
4
C. PREDICATE DEVICES
1 Predicate device for LF-P
| Device Name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| PREDICATE | ||
| OLYMPUS LF-TP AND LF-DP Tracheal Intubation | ||
| Fiberscopes, Accessories and Ancillary Equipment | Olympus Optical Co., | |
| Ltd. | K981543 |
Predicate devices for LF-V .
| Device Name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| PREDICATE | ||
| OLYMPUS LF-TP AND LF-DP Tracheal Intubation | ||
| Fiberscopes, Accessories and Ancillary Equipment | Olympus Optical Co., | |
| Ltd. | K981543 | |
| REFERENCE PREDICATE | ||
| Tracheal Intubation Fibervideoscope LF-Y0004 and LF- | ||
| Y0005 | Olympus Medical | |
| Systems Corp. | K082720 |
D. DEVICE DESCRIPTION
LF-P Device Description
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
LF-V Device Description
The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
5
E. INDICATIONS FOR USE
LF-P Indications for Use
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
LF-V Indications for Use
The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
F. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
| | SUBJECT DEVICE:
LF-P Tracheal Intubation Fiberscope | PRIMARY PREDICATE:
LF-DP Tracheal Intubation Fiberscopes
(K981543) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Olympus Medical | SAME |
| Classification
& Regulation
Number | Class II
21 CFR §874.4680 | SAME |
| Product Code | EOQ - Bronchoscope (Flexible or Rigid) | SAME |
| Intended Use | The TRACHEAL INTUBATION
FIBERSCOPE OLYMPUS LF-P has been
designed to be used with an Olympus video
system center, documentation equipment,
display monitor and other ancillary equipment
for airway management, which includes
endoscopic observation to access airway
anatomy, endotracheal/endobronchial
intubation and management. | These instruments have been designed to be
used with a Suction Pump and other ancillary
equipment for airway management, which
includes observation to access airway anatomy,
endotracheal/endobronchial intubation and
management. Do not use these instruments for
any purpose other than their intended use. |
| Field of View | 75° | 90° |
| Direction of
View | 0° (Forward viewing) | SAME |
| Depth of
Field | 2-50mm | 3-50mm |
| Optimum
Working
Distance | 7.0mm | 6.0mm |
| Insertion
Tube
Diameter | Distal end size: ø 1.8mm
Flexible tube outer Diameter: ø 2.2mm | Distal end size: ø 3.1mm
Flexible tube outer Diameter: ø 3.1mm |
| Insertion
section | 600mm | SAME |
LF-P Tracheal Intubation Fiberscope
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Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A thin, horizontal yellow line is located beneath the word. The registered trademark symbol is located to the right of the word.
| | SUBJECT DEVICE:
LF-P Tracheal Intubation Fiberscope | PRIMARY PREDICATE:
LF-DP Tracheal Intubation Fiberscopes
(K981543) |
|--------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------|
| Working
Length | | |
| Angulation
Range | Up 120° / Down 120° | SAME |
| Light Guide
(LG) Cable
Configuration | Not detachable | Detachable |
LF-V Tracheal Intubation Videoscope
| | SUBJECT DEVICE:
LF-V Tracheal Intubation
Videoscope | PRIMARY PREDICATE:
LF-DP Tracheal
Intubation Fiberscopes
(K981543) | REFERENCE PREDICATE:
LF-Y0004 Tracheal Intubation
Fibervideoscope (K082720) |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Olympus Medical | Olympus Medical | Olympus Medical |
| Classification
& Regulation
Number | Class II
21 CFR §874.4680 | SAME | SAME |
| Product Code | EOQ - Bronchoscope
(Flexible or Rigid) | SAME | SAME |
| Intended Use | The VISERA TRACHEAL
INTUBATION
VIDEOSCOPE OLYMPUS
LF TYPE V has been
designed to be used with a
video system center, light
source, documentation
equipment, display monitor,
suction pump, and other
ancillary equipment for
airway management which
includes endoscopic
observation to access airway
anatomy,
endotracheal/endobronchial
intubation and management. | These instruments have
been designed to be used
with a Suction Pump and
other ancillary equipment
for airway management,
which includes observation
to access airway anatomy,
endotracheal/endobronchial
intubation and management.
Do not use these
instruments for any purpose
other than their intended
use. | These instruments have been
designed to be used with a
Suction Pump and
EndoTherapy accessories and
other ancillary equipment for
airway management, which
includes endoscopic treatment,
diagnosis, and observation to
access airway anatomy,
endotracheal/endobronchial
intubation and management. |
| Field of View | 120° | 90° | 90° |
| Direction of
View | 0° (Forward viewing) | SAME | SAME |
| Depth of Field | 3-50mm | SAME | 4-50 mm |
| Optimum
Working
Distance | 9.0mm | 6.0mm | 9.5mm |
| Insertion
Tube
Diameter | Distal end size: ø 3.8mm
Flexible tube outer
Diameter: ø 4.1mm | Distal end size: ø 3.1mm
Flexible tube outer
Diameter: ø 3.1mm | Distal end size: ø 3.9mm
Flexible tube outer Diameter: ø
4.1mm |
| Insertion
section
Working
Length | 600mm | SAME | SAME |
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Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are a sans-serif font and are closely spaced together. There is a yellow gradient line underneath the word. The registered trademark symbol is located to the right of the letter "S".
| | SUBJECT DEVICE:
LF-V Tracheal Intubation
Videoscope | PRIMARY PREDICATE:
LF-DP Tracheal
Intubation Fiberscopes
(K981543) | REFERENCE PREDICATE:
LF-Y0004 Tracheal Intubation
Fibervideoscope (K082720) |
|--------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Angulation
Range | Up 120° / Down 120° | SAME | SAME |
| Light Guide
(LG) Cable
Configuration | Not detachable | Detachable | None |
G. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
- General
- ISO 14971 (Medical devices Application of risk management to medical I devices)
- Non-Clinical Bench Testing ●
Electrical Testing:
- IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- 트 IEC 60601-1-2 (Medical electrical equipment - Part 1-2: Collateral Standard: Electromagnetic disturbances - Requirements and tests)
- I IEC 60601-2-18 (Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment)
- IEC 62471 (Photobiological safety of lamps and lamp systems)
Performance Testing:
- I ISO 8600 (Endoscopes - Medical endoscopes and endotherapy devices, Part 1: General requirements)
- Composite durability
- I Color performance
- 트 Image intensity uniformity (IIU)
- Field of View and Direction of View
- 트 Resolution
Reprocessing:
- FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- Biocompatibility ●
- ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and 트 testing within a risk management process)
- I ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
- 트 ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for skin
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Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are slightly shadowed, giving them a three-dimensional appearance. Below the word, there is a thin, horizontal, gold bar. The logo is simple and clean, with a focus on the company name.
sensitization)
Clinical Performance Data .
Clinical and animal testing were not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
H. CONCLUSION
In summary the LF-P and LF-V are substantially equivalent to the predicate devices and present no new questions of safety or effectiveness.